Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Bridging Imaging and Pathology: Using Advanced MRI Protocols in Correlation With Extensive Histopathology to Detect Clinically Significant Prostate Cancer
Overview
In recent years, new and promising approaches have emerged in the field of MRI imaging of the prostate. These approaches usually aim to visualise the so-called "microstructures" of the tissue and are intended to offer greater accuracy in the diagnosis of prostate cancer than the current mpMRI examination. To this end, mathematical microstructure models are calculated that determine the proportional presence of histological substructures in specific MRI volumes. Additional new MRI sequences that are not routinely recorded are required to calculate the microstructure models. In order to further investigate the possibilities of these new MRI sequences, this study will compare different mathematical models. In addition, a histopathological examination of the tissue will be performed.
Primary outcome measures
- Comparison of different microstructure models in the performance of detecting csPCa [Time frame: Upon study completion since data from all subjects need to be included (Until 6 months after the last patient got included)]
Eligibility criteria
Inclusion criteria
- Humans with a prostate ≥18 years of age.
- Patients with biopsy-proven PCa who are scheduled for an RPE.
- Signed informed consent form (ICF) that demonstrates study participant understands the purpose of and procedures necessary for the study.
- Willingness, ability, and legal capacity to participate in the study.
- Ability to adhere to the prohibitions and restrictions defined in this protocol.
Exclusion criteria
- Inability to give consent.
- Prior hormone treatment (i.e., androgen deprivation treatment (ADT) and/or 5-ɑ-reductase inhibitors).
- Prior PCa treatment.
- Prior transurethral resection of the prostate (TUR-P) or other prostate surgery.
- Prior total hip arthroplasty on one or both sides or other metal implants that interfere with the MRI acquisition of the hip region.
- General contraindications for an MRI scan (i.e., pacemaker, relevant metal implants, etc.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Instituto do Câncer do Estado de São Paulo — São Paulo
Identifiers
NCT: NCT07432360 · VIRDX 2025_BR